Page 81 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

before sampling starts, particularly so for group specific
research like genetic research;

vii. samples obtained for archival purposes in a prospective
study. (ICMR, 2006, India)

b) Secondary Use:

Every request for secondary use shall be examined by the
NREC/IRB to ensure that:

i. the proposed use does not transgress the original consent
given for the earlier study and the validity of the objectives
of the new study;
ii. provisions for ensuring anonymity of the samples for
secondary use are stated;
iii. after anonymizing sample, results are not communicated to
the donor;
iv. for postmortem uses of samples the permission of the next of
kin, legally authorized representative should be obtained;
and
v. waiver of consent is given whenever the donor is not
traceable or the sample is anonymized. (ICMR, 2006, India)

c) Other Use:

1. Any researcher who intends to use samples from a
Repository must submit a Statement of Research Intent,
which must be approved by the Ethics Committee of the
Repository, which shall be responsible for determining
whether the intended research is consistent with the
informed consent provided by the donor, and, where
applicable, of the group.
2. Unless scientifically essential, the Repository must not
provide to an individual researcher any information linked
to the samples. When linked information is to be provided,
only the minimal information as required for the intended
research shall be provided.

3. If any commercial use is made of the samples in the
Repository, appropriate written benefit-sharing agreements,
consistent with the policies stated earlier, must be jointly
signed by the donor, sample collector and Repository in-
charge. It is also desirable that community consultations are
held prior to collection of samples to be stored in a
Repository, and group consent is obtained before individual
consent.

4. There should be appropriate Material Transfer Agreements
with the Repository for depositing samples as well as for

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 77